Tissue Destruction and Healing in Celiac Disease

NCT ID: NCT05680012

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-14
• Study Completion Date: 2027-06-30

Brief Summary

The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.

Detailed Description

Celiac disease is an autoimmune enteropathy characterized by chronic inflammation of the small intestinal mucosa triggered by gluten uptake that occurs in genetically susceptible individuals carrying the specific class II human leucocyte antigens (HLA) DQ2 and DQ8 alleles. There is a spectrum in intestinal tissue damage associated with celiac disease. Some individuals develop inflammatory immunity in the absence of tissue damage, while others experience tissue damage ranging from partial to total villous atrophy. Persistent mucosal damage is associated with several severe complications, including lymphoproliferative malignancy and bone diseases. In addition, individuals with active celiac disease display a wide range of clinical symptoms, including metabolic defects that are not correlated to the degree of villous atrophy. Although much progress has been made in understanding celiac disease, major gaps remain in understanding biological mechanisms underlying inter-individual differences in clinical presentations and capacity to heal while maintaining a gluten-free diet.

Conditions

Celiac Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gluten challenge group

Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months

Group Type: EXPERIMENTAL

Gluten containing snack bar

Intervention Type: DIETARY_SUPPLEMENT

Ingest snack bars containing 3 grams of gluten every day for 6 weeks.

Gluten de-challenge group

Suspected celiac disease either showing typical symptoms or positive celiac disease serology

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control group

No history or symptoms of celiac disease

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gluten containing snack bar

Ingest snack bars containing 3 grams of gluten every day for 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Gluten challenge group:

1. Age 18 to 75 years old

2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy

3. Follow a strict gluten-free diet for at least the 12 consecutive months

Gluten de-challenge group:

1. Age 18 to 75 years old

2. Showing typical celiac disease symptoms

3. Not on a gluten-free diet

Control group:

1. Age 18 to 75 years old

2. Females who are not pregnant

Exclusion Criteria

Gluten challenge group:

1. Diagnosis of any severe complication of celiac disease

2. Diagnosis of other chronic, active GI disease

3. Selective IgA deficiency

4. Severe reaction to gluten exposure

5. Any clinically significant diseases

6. History of significant substance or alcohol abuse

7. Pregnant or lactating

8. Diagnosis of blood clotting disorders

Gluten de-challenge group:

1. History of chronic inflammatory gastrointestinal disease

2. Gastrointestinal illness within the 4-week period prior to screening

3. History of lymphoproliferative disease

4. Uncontrolled blood clotting disorders

5. Any clinically significant diseases

6. History of significant substance or alcohol abuse

Control group:

1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs

2. Known intestinal inflammation

3. Prior gastrointestinal surgery

4. Taking of antiplatelet agents or anticoagulants

5. Family history of celiac disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

California Institute of Technology

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bana Jabri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

California Institute of Technology

Pasadena, California, United States

Site Status: NOT_YET_RECRUITING

The University of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sonia Kupfer, MD

Role: CONTACT

skupfer@bsd.uchicago.edu

(773) 834-1438

Kristi Kearney, RN

Role: CONTACT

kkearney@bsd.uchicago.edu

773-834-7414

Facility Contacts

Rustem Ismagilov, PhD

Role: primary

rustem.admin@caltech.edu

626-395-8130

Bana Jabri, MD

Role: primary

bjabri@bsd.uchicago.edu

Sonia Kupfer, MD

Role: backup

skupfer@bsd.uchicago.edu

Joseph Murray, MD

Role: primary

Murray.Joseph@mayo.edu

Chadrick Hinson

Role: backup

Hinson.chadrick@mayo.edu

507-266-0237

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RC2DK133947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB22-1138

Identifier Type: -

Identifier Source: org_study_id